Lean Validation (Process, System, Cleaning, Equipment)

Independent Solutions provide full System Life-Cycle (SLC) validation for computer systems ranging from small systems to large-scale (Enterprise Resource Planning) systems in accordance with site requirements, GAMP, FDA & EU standards. This involves the development & execution (where applicable) of the following documentation:

• Regulatory Assessment
• Project Scope
• Validation Project Plan (VPP)
• User Requirements Specification (URS)
• Functional Specification (FS)
• Functional Design Specification (FDS)
• Hardware Design Specification (HDS)
• Configuration Specifications (CS)
• Risk Assessments
• Part 11 Compliance Assessment
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)
• Supplier Auditing
• Installation Qualification (IQ) protocols and Reports
• Operational Qualification (OQ) protocols and Reports
• Performance Qualification (PQ) protocols and Reports
• Performance Monitoring Protocol
• Requirements Traceability Matrix (RTM)
• Validation Summary Report
• Computer Systems Decommissioning
• SOP development
• Disaster Recovery Plan
• Business Continuity Plan
• Periodic Review
• Training Plans

Chromatography Systems, Labeling Systems, ERP Systems, Laboratory Systems & Calibration Systems.